About the Job:
The IHC Lead Technologist performs and leads day-to-day routine Immunohistochemistry (IHC) testing on patient samples in a high complex clinical diagnostic laboratory using a variety of automated platforms for microscopic examination and analysis by the Pathologist. The incumbent has a strong knowledge of accreditation and regulatory standards. In addition, the IHC Lead Technologist demonstrates a commitment to meeting TAT objectives, quality metrics, key performance indicators, and ensuring an environment of continuous improvement.
The IHC Lead Technologist may be asked to cover scheduling gaps and is included in the on-call rotation for additional weekend and/or holiday technical support.
This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
Key Responsibilities:
Lead day-to-day activities and workflow of the clinical IHC laboratory.
Perform Automated Immunohistochemistry (IHC) using both the Dako Autostainer Link 48 and Ventana Benchmark Ultra Staining Systems.
Operate a microtome to produce slides from paraffin blocks.
Perform QC and/or verification steps for receiving and delivering specimens for IHC staining.
Perform the assigned tests or components of the test in accordance with assay run schedule, accurately, and within TAT and always in compliance with written SOPs.
Finalize test orders to deliver to requesting pathologist.
Lead or coordinate tissue, reagent, and assay quality control and validations as needed.
Perform routine H&E staining with possible other histological staining methods introduced over time.
Maintain proper sample chain of custody including proper specimen handling, labeling, and preparation of batch records.
Maintain adequate stock and efficient use of supplies necessary for performing all procedures, and preparation of reagents as required.
Assist in maintaining an organized lab space.
Follow written lab Standard Operating procedures for the correct handling and processing of specimens.
Maintain a deep understanding of laboratory processes to ensure effective troubleshooting of assays and instrumentation.
Serve as a technical resource for problem solving and process improvement to ensure accurate test performance and meets all quality goals.
Demonstrate capability of identifying problems that may adversely affect test performance or reporting of tests results and takes appropriate action.
Maintain attention to detail for quality completion of each task.
Maintain and troubleshoot equipment/instrumentations.
Communicate with the Asset Management team and IHC Supervisors when equipment needs repair.
Assist in the development of competency, training, and orientation of the IHC staff.
Support department supervisor on any employee related concerns.
Effectively communicate deficiencies to appropriate personnel, including deficiencies related to specimens, paperwork, database information, and equipment.
Investigate Root Cause Analysis (RCA), write Incident/Event Report (INC), Non-Conformance Report (NCR), and Corrective Action & Preventative Action (CAPA).
Troubleshoot issues while working with staff to document the quality issues.
Participate on cross-functional teams to coordinate troubleshooting, process improvements, SOP revisions, and/or implement new workflows or products.
Monitor and communicate inventory of supply and reagent needs as they diminish.
Assist with equipment validation (find cases, work through optimization, etc.) and work with outside vendors, when required.
Operate and maintain all IHC lab equipment in proper state of readiness and cleanliness. Record and monitor monthly logs for all required areas.
Collect and publish routine processing and operational metrics and execute countermeasures to ensure daily processing goals are met.
Ensure that quality tissue specimen slides and stain…